What changed
Affected convenience kits must be corrected by removing the Medline Namic Off Handle Manifolds, and warning labels must be added to prevent their usage until corrected.
Why it matters
Failure to correct these kits poses a high risk of serious injury or death to patients. The FDA classifies this recall as the most serious type, underscoring the urgent need for compliance.
Action needed
All impacted products must be identified, segregated, and quarantined. Users are required to add appropriate warning labels and must exercise extreme caution if using the Manifolds is unavoidable.